Literature DB >> 26942455

Perceptibility and the "Choice Experience": User Sensory Perceptions and Experiences Inform Vaginal Prevention Product Design.

Kate Morrow Guthrie1,2,3, Shira Dunsiger1,3, Sara E Vargas1,2, Joseph L Fava1, Julia G Shaw1, Rochelle K Rosen1,3, Patrick F Kiser4, E Milu Kojic5,6, David R Friend7, David F Katz8.   

Abstract

The development of pericoital (on demand) vaginal HIV prevention technologies remains a global health priority. Clinical trials to date have been challenged by nonadherence, leading to an inability to demonstrate product efficacy. The work here provides new methodology and results to begin to address this limitation. We created validated scales that allow users to characterize sensory perceptions and experiences when using vaginal gel formulations. In this study, we sought to understand the user sensory perceptions and experiences (USPEs) that characterize the preferred product experience for each participant. Two hundred four women evaluated four semisolid vaginal formulations using the USPE scales at four randomly ordered formulation evaluation visits. Women were asked to select their preferred formulation experience for HIV prevention among the four formulations evaluated. The scale scores on the Sex-associated USPE scales (e.g., Initial Penetration and Leakage) for each participant's selected formulation were used in a latent class model analysis. Four classes of preferred formulation experiences were identified. Sociodemographic and sexual history variables did not predict class membership; however, four specific scales were significantly related to class: Initial Penetration, Perceived Wetness, Messiness, and Leakage. The range of preferred user experiences represented by the scale scores creates a potential target range for product development, such that products that elicit scale scores that fall within the preferred range may be more acceptable, or tolerable, to the population under study. It is recommended that similar analyses should be conducted with other semisolid vaginal formulations, and in other cultures, to determine product property and development targets.

Entities:  

Keywords:  HIV/STI; adherence; dosage forms; perceptibility; prevention; product choice

Mesh:

Substances:

Year:  2016        PMID: 26942455      PMCID: PMC5067921          DOI: 10.1089/AID.2015.0275

Source DB:  PubMed          Journal:  AIDS Res Hum Retroviruses        ISSN: 0889-2229            Impact factor:   2.205


  20 in total

1.  Design of a semisolid vaginal microbicide gel by relating composition to properties and performance.

Authors:  Alamelu Mahalingam; Eric Smith; Judit Fabian; Festo R Damian; Jennifer J Peters; Meredith R Clark; David R Friend; David F Katz; Patrick F Kiser
Journal:  Pharm Res       Date:  2010-09-15       Impact factor: 4.200

2.  Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.

Authors:  Quarraisha Abdool Karim; Salim S Abdool Karim; Janet A Frohlich; Anneke C Grobler; Cheryl Baxter; Leila E Mansoor; Ayesha B M Kharsany; Sengeziwe Sibeko; Koleka P Mlisana; Zaheen Omar; Tanuja N Gengiah; Silvia Maarschalk; Natasha Arulappan; Mukelisiwe Mlotshwa; Lynn Morris; Douglas Taylor
Journal:  Science       Date:  2010-07-19       Impact factor: 47.728

3.  Assessing microbicide acceptability: a comprehensive and integrated approach.

Authors:  Kathleen M Morrow; Monica S Ruiz
Journal:  AIDS Behav       Date:  2007-06-26

Review 4.  Vaginal drug delivery systems for HIV prevention.

Authors:  Lisa Cencia Rohan; Alexandra B Sassi
Journal:  AAPS J       Date:  2009-02-05       Impact factor: 4.009

5.  Designing preclinical perceptibility measures to evaluate topical vaginal gel formulations: relating user sensory perceptions and experiences to formulation properties.

Authors:  Kathleen M Morrow; Joseph L Fava; Rochelle K Rosen; Sara Vargas; Julia G Shaw; E Milu Kojic; Patrick F Kiser; David R Friend; David F Katz
Journal:  AIDS Res Hum Retroviruses       Date:  2013-12-09       Impact factor: 2.205

6.  Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women.

Authors:  Wafaa M El-Sadr; Kenneth H Mayer; Lisa Maslankowski; Craig Hoesley; Jessica Justman; Fang Gai; Christine Mauck; Judith Absalon; Kathleen Morrow; Benoît Mâsse; Lydia Soto-Torres; Antonia Kwiecien
Journal:  AIDS       Date:  2006-05-12       Impact factor: 4.177

7.  Design of tenofovir-UC781 combination microbicide vaginal gels.

Authors:  Patrick F Kiser; Alamelu Mahalingam; Judit Fabian; Eric Smith; Festo R Damian; Jennifer J Peters; David F Katz; Hoda Elgendy; Meredith R Clark; David R Friend
Journal:  J Pharm Sci       Date:  2012-02-22       Impact factor: 3.534

8.  Acceptability of a microbicide among women and their partners in a 4-country phase I trial.

Authors:  Margaret E Bentley; Andrew M Fullem; Elizabeth E Tolley; Clifton W Kelly; Neelam Jogelkar; Namtip Srirak; Liness Mwafulirwa; Gertrude Khumalo-Sakutukwa; David D Celentano
Journal:  Am J Public Health       Date:  2004-07       Impact factor: 9.308

9.  Acceptability of tenofovir gel as a vaginal microbicide among women in a phase I trial: a mixed-methods study.

Authors:  Rochelle K Rosen; Kathleen M Morrow; Alex Carballo-Diéguez; Joanne E Mantell; Susie Hoffman; Fang Gai; Lisa Maslankowski; Wafaa M El-Sadr; Kenneth H Mayer
Journal:  J Womens Health (Larchmt)       Date:  2008-04       Impact factor: 2.681

10.  Acceptability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa.

Authors:  Gita Ramjee; Neetha S Morar; Sarah Braunstein; Barbara Friedland; Heidi Jones; Janneke van de Wijgert
Journal:  AIDS Res Ther       Date:  2007-09-27       Impact factor: 2.250

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  10 in total

1.  A Qualitative Systematic Review of Women's Experiences Using Contraceptive Vaginal Rings: Implications for New Technologies.

Authors:  Sara E Vargas; Miriam M Midoun; Melissa Guillen; Melissa L Getz; Kristen Underhill; Caroline Kuo; Kate M Guthrie
Journal:  Perspect Sex Reprod Health       Date:  2019-05-20

2.  The Role of Volume in the Perceptibility of Topical Vaginal Formulations: User Sensory Perceptions and Experiences of Heterosexual Couples During Vaginal Sex.

Authors:  Kate M Guthrie; Joseph L Fava; Sara E Vargas; Rochelle K Rosen; Julia G Shaw; Erna M Kojic; Anthony S Ham; Lisa C Rohan; David Katz; Anacecilia Panameño; Christopher Colleran; David F Friend; Karen W Buckheit; Robert W Buckheit
Journal:  AIDS Res Hum Retroviruses       Date:  2020-11-03       Impact factor: 2.205

3.  Vaginal film for prevention of HIV: using visual and tactile evaluations among potential users to inform product design.

Authors:  K M Guthrie; L Rohan; R K Rosen; S E Vargas; J G Shaw; D Katz; E M Kojic; A S Ham; D Friend; K W Buckheit; R W Buckheit
Journal:  Pharm Dev Technol       Date:  2017-06-21       Impact factor: 3.133

4.  User input in iterative design for prevention product development: leveraging interdisciplinary methods to optimize effectiveness.

Authors:  Kate M Guthrie; Rochelle K Rosen; Sara E Vargas; Melissa Guillen; Arielle L Steger; Melissa L Getz; Kelley A Smith; Jaime J Ramirez; Erna M Kojic
Journal:  Drug Deliv Transl Res       Date:  2017-10       Impact factor: 4.617

5.  Designing Dual Compartment HIV Prevention Products: Women's Sensory Perceptions and Experiences of Suppositories for Rectal and Vaginal Use.

Authors:  Kate M Guthrie; Rochelle K Rosen; Melissa Guillen; Jaime J Ramirez; Sara E Vargas; Joseph L Fava; Anthony S Ham; David F Katz; Susan Cu-Uvin; Sheila Tumilty; Kelley A Smith; Karen W Buckheit; Robert W Buckheit
Journal:  AIDS Res Hum Retroviruses       Date:  2021-10-18       Impact factor: 1.723

6.  Users' Preferred Characteristics of Vaginal Rings for HIV Prevention: A Qualitative Analysis of Two Phase I Trials.

Authors:  Imogen Hawley; Mei Song; Rachel Scheckter; Tara McClure; Jeanna Piper; Beatrice A Chen; Craig Hoesley; Albert Y Liu; Ariane van der Straten
Journal:  AIDS Res Hum Retroviruses       Date:  2022-02-11       Impact factor: 1.723

7.  A Comparative Pre-Phase I Study of the Impact of Gel Vehicle Volume on Distal Colon Distribution, User Experience, and Acceptability.

Authors:  Ethel D Weld; Hiwot Hiruy; Kate Morrow Guthrie; Joseph L Fava; Sara E Vargas; Karen Buckheit; Robert Buckheit; Hans Spiegel; Jennifer Breakey; Edward J Fuchs; Craig W Hendrix
Journal:  AIDS Res Hum Retroviruses       Date:  2016-12-13       Impact factor: 2.205

8.  The new contraceptive revolution: developing innovative products outside of industry†,‡.

Authors:  Rebecca L Callahan; Neha J Mehta; Kavita Nanda; Gregory S Kopf
Journal:  Biol Reprod       Date:  2020-08-04       Impact factor: 4.285

9.  User evaluations offer promise for pod-intravaginal ring as a drug delivery platform: A mixed methods study of acceptability and use experiences.

Authors:  Kate M Guthrie; Rochelle K Rosen; Sara E Vargas; Melissa L Getz; Lauren Dawson; Melissa Guillen; Jaime J Ramirez; Marc M Baum; Kathleen L Vincent
Journal:  PLoS One       Date:  2018-05-14       Impact factor: 3.240

10.  Qualitative exploration of intrinsic and extrinsic factors that influence acceptability of semisoft vaginal suppositories.

Authors:  Toral Zaveri; Kimberly A Powell; Kate M Guthrie; Alyssa J Bakke; Gregory R Ziegler; John E Hayes
Journal:  BMC Womens Health       Date:  2018-10-20       Impact factor: 2.809

  10 in total

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